The Harvard Drug Group recalls
Every recall we track for The Harvard Drug Group — 45 in all, from 2016–2023 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from The Harvard Drug Group peaked in 2017 (25); 43 since 2017. 5% rated “stop using now”.
All FDA recall records for The Harvard Drug Group since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 2 | 1 | 0 | 22 | 25 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 1 | 5 | 2 | 8 |
| 2021 | 0 | 1 | 2 | 1 | 4 |
| 2022 | 0 | 1 | 0 | 1 | 2 |
| 2023 | 0 | 1 | 2 | 0 | 3 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
The Harvard Drug Group recalls before 2017
Recalls on record by year.
Most common reasons for The Harvard Drug Group recalls
What to do if you have a recalled The Harvard Drug Group product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All The Harvard Drug Group recalls
21 shown- Use cautionDrug
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical
The Harvard Drug Group is recalling Tramadol Hydrochloride Tablets, USP 50 mg due to blister packaging that may be inadequately sealed.
The Harvard Drug GroupJun 16, 2023 - Lower riskDrug
The Harvard Drug Group recalls Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only,
Harvard Drug Group recalls 600mg Gabapentin tablets (NDC 0904-6823-61) after finding a foreign tablet in some products. This recall is for prescription-only items sold between specific dates.
The Harvard Drug GroupApr 24, 2023 - Lower riskDrug
The Harvard Drug Group recalls Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by:
The Harvard Drug Group recalls Carbidopa and Levodopa tablets due to blister packaging that may not seal properly. This could lead to medication exposure risks for patients using prescription medication.
The Harvard Drug GroupFeb 23, 2023 - Use cautionDrug
The Harvard Drug Group recalls PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by:
The Harvard Drug Group is recalling Paliperidone Extended-Release Tablets, 9 mg due to failed dissolution specifications. Check your lot numbers and expiration dates.
The Harvard Drug GroupFeb 28, 2022 - UnratedDrug
The Harvard Drug Group recalls hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR
The Harvard Drug Group recalls 10 mg hydrALAZINE HCl tablets due to impurities found in stability testing. This affects specific lots from March 2023. No remedy is stated in the recall notice.
The Harvard Drug GroupFeb 24, 2022 - Lower riskDrug
The Harvard Drug Group recalls Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent
The Harvard Drug Group recalls Carbamazepine 200mg tablets due to failed dissolution specifications. This may affect medication effectiveness. Check your product details to see if you are affected.
The Harvard Drug GroupAug 6, 2021 - UnratedDrug
The Harvard Drug Group recalls Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N.
Harvard Drug Group recalls 60mg fexofenadine tablets with impurities that could pose health risks. Affected lots expired by April 2022. Consumers should check NDC 0904-6979-40 and lot numbers.
The Harvard Drug GroupAug 3, 2021 - Lower riskDrug
The Harvard Drug Group recalls Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals,
Harvard Drug Group recalls 200mg Entacapone Tablets due to failed dissolution specifications. Affected units have specific NDC and lot numbers. Consumers should contact the manufacturer for details.
The Harvard Drug GroupJul 29, 2021 - Use cautionDrug
The Harvard Drug Group recalls NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b)
The Harvard Drug Group recalls specific lots of Nifedipine 30mg extended-release tablets due to failed dissolution specifications. Check your lot numbers and expiration dates.
The Harvard Drug GroupJul 2, 2021 - UnratedDrug
The Harvard Drug Group recalls Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto,
Harvard Drug Group recalls 15mg Aripiprazole tablets with failed dissolution specs. Affected lots T02520 and T02637 expired 02/2021. No remedy stated in recall notice.
The Harvard Drug GroupNov 18, 2020 - UnratedDrug
The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only,
The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets (500mg) due to potential presence of NDMA impurity above safe levels. This recall affects specific lot numbers and distribution channels.
The Harvard Drug GroupJun 12, 2020 - Use cautionDrug
The Harvard Drug Group recalls Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit
The Harvard Drug Group is recalling specific lots of Doxycycline Hyclate Tablets, USP, 100 mg due to failed dissolution specifications at the end of shelf life.
The Harvard Drug GroupMay 22, 2020 - Lower riskDrug
The Harvard Drug Group recalls Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:
Harvard Drug Group recalls 28mg Memantine Hydrochloride Extended-Release Capsules due to failed dissolution testing in stability checks. This affects Rx-only products with specific NDC and lot numbers.
The Harvard Drug GroupApr 24, 2020 - Lower riskDrug
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets due to incorrect package insert. This may cause confusion about proper use. Contact for details.
The Harvard Drug GroupFeb 27, 2020 - Lower riskDrug
The Harvard Drug Group recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only,
The Harvard Drug Group recalls 28mg Memantine Hydrochloride Extended-release Capsules due to failed dissolution specifications observed in stability studies. This may affect medication effectiveness.
The Harvard Drug GroupDec 13, 2019 - UnratedDrug
The Harvard Drug Group recalls Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma
Harvard Drug Group recalls 0.25mg Alprazolam tablets with unknown impurity. Consumers should contact the manufacturer for details on affected lots.
The Harvard Drug GroupSep 26, 2017 - Stop using nowDrug
The Harvard Drug Group recalls Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:
The Harvard Drug Group recalls Rugby Diocto Syrup due to microbial contamination including yeast and potential B. cepacia. Consumers should stop using affected bottles.
The Harvard Drug GroupAug 2, 2017 - Stop using nowFood
The Harvard Drug Group recalls Major Ferrous Drops, 1 2/3 oz (50 mL)
The Harvard Drug Group recalls Major Ferrous Drops due to possible B. cepacia contamination, which may cause serious infections in vulnerable patients.
MajorAug 2, 2017 - Use cautionDrug
The Harvard Drug Group recalls Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories
The Harvard Drug Group is recalling Fluconazole Tablets, USP 200 mg due to failed dissolution specifications. Check your lot number and expiration date.
The Harvard Drug GroupJan 5, 2017 - Use cautionDrug
The Harvard Drug Group recalls Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada,
The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg due to out-of-specification assay results. Check your lot number and expiration date.
The Harvard Drug GroupDec 27, 2016 - Stop using nowDrug
The Harvard Drug Group recalls Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby
The Harvard Drug Group recalls Diocto Liquid stool softener due to Burkholderia cepacia contamination. Check lot numbers and expiration dates for affected bottles.
DioctoJul 15, 2016
The Harvard Drug Group recall questions
How many recalls has The Harvard Drug Group had?
45 recalls from The Harvard Drug Group are on record with U.S. safety agencies, from 2016–2023 (28 drug, 17 food).
What is the most recent The Harvard Drug Group recall?
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical, dated Jun 16, 2023. Every The Harvard Drug Group recall is listed on this page, newest first.
Why are The Harvard Drug Group products recalled?
The most common reasons on record: Failed Dissolution Specifications (5).
What should I do if I have a recalled The Harvard Drug Group product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new The Harvard Drug Group recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.