Lupin Recalls Cefdinir Powder for Oral Suspension Due to Superpotency
Lupin Pharmaceuticals is voluntarily recalling 40,824 bottles of Cefdinir powder for oral suspension because the drug was found to be superpotent.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the hazard involves significant potential for harm such as superpotency, even if specific hospitalization reports are not detailed in the text.
Plain-English summary
Lupin Pharmaceuticals Inc. is voluntarily recalling 40,824 bottles of Cefdinir powder for Oral Suspension USP, 250 mg/5 mL. The affected products are available in 60 mL packs (NDC 68180-723-20) and 100 mL packs (NDC 68180-723-10). The recall was initiated on March 27, 2018, and the products were distributed nationwide.
The reason for the recall is that the drug was identified as superpotent. The FDA has classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The specific lots affected are F602241 (Exp. 10/18), F602577 (Exp. 11/18), and F700036 (Exp. 12/18).
Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase. The recall status is currently terminated as of April 15, 2019.
The recalled product
- Product
- CEFDINIR (CEFDINIR)
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 40,824
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # F602241
- Exp. 10/18 Lot # F602577
- Exp. 11/18 Lot # F700036
- Exp. 12/18
UPCs (1)
- 0368180723042
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CEFDINIR
- HighCefdinir Oral Suspension recalled nationwide for defective container seals
FDA (Drugs) · 2024-06-05
- HighAntibiotic Cefdinir Oral Suspension Recalled Over Foreign Material
FDA (Drugs) · 2024-05-22
- HighAntibiotic Cefdinir Oral Suspension Recalled for Foreign Material Contamination
FDA (Drugs) · 2024-05-22
- SevereLupin Recalls Cefdinir Oral Suspension Due to Out-of-Specification Assay Results
FDA (Drugs) · 2020-07-29
- LowLupin Recalls Cefdinir Oral Suspension Due to Foreign Substance
FDA (Drugs) · 2019-11-13
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateSertraline tablets recalled because bottle seals are not adhering
FDA (Drugs) · 2025-12-17
Same hazard · superpotency
See all →- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
- ModerateTriamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance
FDA (Drugs) · 2024-11-27