Hikma Pharmaceuticals USA INC recalls
Every recall we track for Hikma Pharmaceuticals USA INC — 20 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Hikma Pharmaceuticals USA INC peaked in 2020 (6); 20 since 2017. 10% rated “stop using now”.
All FDA recall records for Hikma Pharmaceuticals USA 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 | 2 | 0 | 0 | 0 | 2 |
| 2020 | 0 | 1 | 4 | 1 | 6 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 1 | 4 | 5 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 1 | 1 | 2 |
| 2025 | 0 | 0 | 0 | 1 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 1 | 2 |
What to do if you have a recalled Hikma Pharmaceuticals USA 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 Hikma Pharmaceuticals USA INC recalls
15 shown- UnratedDrug
Hikma Pharmaceuticals USA INC. recalls Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05)
Hikma Pharmaceuticals recalls 10mg Ramipril capsules due to failed impurities test. Products may contain dicyclohexylurea (DCU) which could cause harm. Check NDC codes 76282-673-01 or 76282-673-05 for affected lots.
Hikma PharmaceuticalsAug 24, 2026 - Lower riskDrug
Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma
Hikma Pharmaceuticals recalls 4 x 75 mL Alendronate Sodium Oral Solution bottles with out of specification assay results due to improper storage. Affected lots were stored on side and may not contain correct medication levels.
HikmaApr 7, 2026 - UnratedDrug
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922,
Hikma Pharmaceuticals recalls Lorazepam injection vials due to impurities that may cause serious harm. Affected products include 25 x 1mL vials with lot # K24118, expiring 10/31/2026. No remedy specified.
Hikma PharmaceuticalsJul 22, 2025 - UnratedDrug
Hikma Pharmaceuticals USA Inc. recalls Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only,
Hikma Pharmaceuticals recalls acetaminophen injection due to label mix-up with dexmedetomidine. This could lead to incorrect medication use. Check your product details and contact Hikma for guidance.
Hikma PharmaceuticalsJul 8, 2024 - Lower riskDrug
Hikma Pharmaceuticals USA Inc. recalls Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley
Hikma recalls Infumorph morphine solution ampules due to expired filter in carton. This could lead to ineffective medication if used after expiration. Check your lot numbers for affected batches.
HikmaMar 12, 2024 - Lower riskDrug
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC
Hikma Pharmaceuticals recalls Lorazepam injection vials due to impurities that could cause harm. Affected lots expire July 2023. Contact for details.
Hikma PharmaceuticalsMay 11, 2023 - Lower riskDrug
Hikma Pharmaceuticals USA Inc. recalls Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE
Hikma Pharmaceuticals recalls Ganciclovir injection vials due to mislabeling with Cladribine. Affected units may contain incorrect labeling that could lead to medication errors.
HikmaDec 16, 2022 - UnratedDrug
Hikma Pharmaceuticals USA Inc. recalls Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward
Hikma Pharmaceuticals recalls Ativan injection due to failed impurities testing. This medication may contain harmful substances that could cause health issues. Affected lots: Lot #060064Z, Exp. 06/2023.
Hikma PharmaceuticalsJul 11, 2022 - Lower riskDrug
Hikma Pharmaceuticals USA Inc. recalls Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie
Hikma Pharmaceuticals recalls Bleomycin injection vials due to mislabeling. This may affect patients using prescription cancer treatment. Contact Hikma for details.
HikmaAug 5, 2021 - UnratedDrug
Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ
Hikma Pharmaceuticals recalls 0.9% Sodium Chloride Injection vials with failed pH tests. These vials may not be safe for medical use. Check your vial's lot number and expiration date to see if it's affected.
Hikma PharmaceuticalsDec 7, 2020 - Lower riskDrug
Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile
Hikma Pharmaceuticals recalls 0.9% Sodium Chloride Injection vials with failed pH tests. These products may not meet USP standards and could cause issues if used in medical procedures.
Hikma PharmaceuticalsNov 3, 2020 - Lower riskDrug
Hikma Pharmaceuticals USA Inc. recalls Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:
Hikma Pharmaceuticals recalls 0.3 mg/mL Buprenorphine HCl injection vials due to sub-potent drug levels found in stability testing. Affected lots expire 02/28/2021.
Hikma PharmaceuticalsAug 14, 2020 - Lower riskDrug
Hikma Pharmaceuticals USA Inc. recalls Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben
Hikma Pharmaceuticals recalls Irinotecan HCL injection vials due to crimp defect causing flip-cap removal issues. Affected lots expire 08/2021 or 09/2021.
Hikma PharmaceuticalsJun 11, 2020 - Use cautionDrug
Hikma Pharmaceuticals USA Inc. recalls methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL),
Hikma Pharmaceuticals recalls 4840 vials of methylPREDNISolone Sodium Succinate due to incorrect reconstitution instructions on the label.
Hikma PharmaceuticalsJan 14, 2020 - Stop using nowDrug
Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25
Hikma Pharmaceuticals recalls Ketorolac injection vials with polydimethylsiloxane particles. Stop using if you have these specific vials. No remedy provided in official notice.
Hikma PharmaceuticalsDec 17, 2019
Hikma Pharmaceuticals USA INC recall questions
How many recalls has Hikma Pharmaceuticals USA INC had?
20 recalls from Hikma Pharmaceuticals USA INC are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Hikma Pharmaceuticals USA INC recall?
Hikma Pharmaceuticals USA INC. recalls Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05), dated Aug 24, 2026. Every Hikma Pharmaceuticals USA INC recall is listed on this page, newest first.
What should I do if I have a recalled Hikma Pharmaceuticals USA 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 Hikma Pharmaceuticals USA 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.