Granules Pharmaceuticals Inc. recalls
Every recall we track for Granules Pharmaceuticals Inc. — 11 in all, from 2020–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Granules Pharmaceuticals Inc. doubled in 2025 (6, up from 3 in 2024).
All FDA recall records for Granules Pharmaceuticals Inc. 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 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 1 | 2 | 0 | 3 |
| 2025 | 0 | 1 | 0 | 5 | 6 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
Most common reasons for Granules Pharmaceuticals Inc. recalls
What to do if you have a recalled Granules Pharmaceuticals Inc. 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 Granules Pharmaceuticals Inc. recalls
7 shown- Lower riskDrug
Granules Pharmaceuticals Inc. recalls Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500
Granules Pharmaceuticals recalls 50mg Trazodone 100-count bottles due to foreign tablets/capsules. Rx-only medication manufactured in India, batch 6160008A, expires Dec 2026.
Granules PharmaceuticalsJan 26, 2026 - UnratedDrug
Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate,
Granules Pharmaceuticals is recalling 20mg amphetamine capsules (NDC 70010-032-01) due to failed impurities and degradation specifications. This is a prescription product with a lot number of GPC250179A and expiration date 06-22-2027.
Granules PharmaceuticalsAug 28, 2025 - Use cautionDrug
Granules Pharmaceuticals Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b)
Granules Pharmaceuticals recalls specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications in stability studies.
Granules PharmaceuticalsJun 24, 2025 - Lower riskDrug
Granules Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules
Granules Pharmaceuticals recalls 500mg Metformin ER tablets (1000-count) due to paracetamol contamination. Rx-only product manufactured in India, shipped to US. Consumers should check NDC 82009-117-10 and lot number 4911311A.
GranulesDec 30, 2024 - Use cautionDrug
Granules Pharmaceuticals Inc. recalls Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA
Granules Pharmaceuticals recalls 96 bottles of Colchicine Capsules 0.6 mg due to failed dissolution specifications. Check your lot number GPC240763B.
Granules PharmaceuticalsDec 18, 2024 - Lower riskDrug
Granules Pharmaceuticals Inc. recalls Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081,
Granules Pharmaceuticals recalls 600mg Gabapentin tablets (500-count) with metformin tablets found inside. Consumers should check lot numbers and contact the company for details.
Granules PharmaceuticalsJul 31, 2024 - Use cautionDrug
Granules Pharmaceuticals Inc recalls Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle
Granules Pharmaceuticals recalls specific lots of Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity levels exceeding FDA limits.
Granules PharmaceuticalsJul 3, 2020
Granules Pharmaceuticals Inc. recall questions
How many recalls has Granules Pharmaceuticals Inc. had?
11 recalls from Granules Pharmaceuticals Inc. are on record with U.S. safety agencies, from 2020–2026.
What is the most recent Granules Pharmaceuticals Inc. recall?
Granules Pharmaceuticals Inc. recalls Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500, dated Jan 26, 2026. Every Granules Pharmaceuticals Inc. recall is listed on this page, newest first.
Why are Granules Pharmaceuticals Inc. products recalled?
The most common reasons on record: Failed Impurities/Degradation Specifications: (5).
What should I do if I have a recalled Granules Pharmaceuticals Inc. 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 Granules Pharmaceuticals Inc. 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.